Manifold for automatic drug compounder

ABSTRACT

A manifold for control of fluid and/or vapor flow between a container and a pump cartridge for a compounder system is provided. One or more manifolds may be disposed in a magazine configured to secure and align the manifolds with a plurality of ports in the cartridge. Each manifold may include a needle having forward and rear openings to a central bore. A needle housing may include a slot configured to receive a push rod for actuating the needle forward and backward. In a forward, engaged position, the openings in the needle may be disposed on opposite sides of a sealing member of the manifold to form a fluid pathway through the manifold. In a rearward, disengaged position, both the forward and rear openings in the needle may be disposed on the same side of the sealing member to prevent fluid and vapor from flowing through the manifold.

REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/780,609, filed on May 31, 2018, issued as U.S. Pat. No. 10,954,007,on Mar. 23, 2021, which is the National Stage Entry ofPCT/US2016/064021, filed on Nov. 29, 2016, and claims priority to U.S.Provisional Patent Application No. 62/263,562, filed Dec. 4, 2015, theentire disclosure of each of these applications being incorporatedherein by this reference.

TECHNICAL FIELD

The present disclosure generally relates to an apparatus thatreconstitutes, mixes, and delivers a drug from a vial to a receivingcontainer. Specifically, the present disclosure relates to a disposablemagazine and manifold providing closed system diluent and waste pathsfor reconstitution of a drug, delivery of diluents from hung diluentbags and diluent vials to medication vials, filling of a receivingcontainer, and removal of waste to a waste container.

BACKGROUND

Pharmaceutical compounding is the practice of creating a specificpharmaceutical product to fit the unique need of a patient. In practice,compounding is typically performed by a pharmacist, tech or a nurse whocombines the appropriate ingredients using various tools. One commonform of compounding comprises the combination of a powdered drugformulation with a specific diluent to create a suspended pharmaceuticalcomposition. These types of compositions are commonly used inintravenous/parenteral medications. It is vital that the pharmaceuticalsand diluents are maintained in a sterile state during the compoundingprocess, and there exists a need for automating the process whilemaintaining the proper mixing characteristics (i.e., certainpharmaceuticals must be agitated in specific ways so that thepharmaceutical is properly mixed into solution but the solution is notfrothed and air bubbles are not created). There exists a need for acompounding system that is easy to use, may be used frequently andefficiently, is reliable and reduces user error.

SUMMARY

A manifold for control of fluid and/or vapor flow between a containerand a pump cartridge for a compounder system is provided.

In accordance with an embodiment, a manifold is provided that includes ahousing; a cap assembly having a first sealing member; a needle guideassembly having a second sealing member; and a needle assembly having aneedle with a central bore, a first opening, and a second opening, wherethe needle assembly is extendible from a disengaged position in whichthe first and second openings are both disposed on a common side of thefirst sealing member between the first and second sealing members and anengaged position in which the first and second openings are disposed onopposing sides of the first sealing member.

In accordance with another embodiment, a compounder system is providedthat includes a pump head assembly having a recess and a plurality ofoperational mechanisms; a magazine configured to be received in therecess; a manifold configured to be received in the magazine; acontainer fluidly coupled to the manifold; and a pump cartridgeconfigured to be operated by the plurality of operational mechanisms ofthe pump drive to pump a fluid from the container through the manifoldinto the pump cartridge, where the manifold comprises a needle assemblyhaving a disengaged configuration in which the needle assembly iscompletely disposed within the manifold such that the manifold preventsflow of the fluid and an engaged configuration in which the needle ofthe needle assembly extends from the manifold into the pump cartridgesuch that the needle forms a portion of a sealed fluid pathway from thecontainer to the pump cartridge.

In accordance with another embodiment, a method is provided thatincludes providing a plurality of manifolds in a magazine, each manifoldfluidly coupled by tubing to a container; providing the magazine in arecess of a pump head assembly of a compounder system; aligning theplurality of manifolds with a corresponding plurality of ports in a pumpcartridge; and extending a needle from at least one of the manifoldsinto the corresponding port in the pump cartridge to create a fluidpathway between the container that is fluidly coupled to that manifoldand the pump cartridge.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide furtherunderstanding and are incorporated in and constitute a part of thisspecification, illustrate disclosed embodiments and together with thedescription serve to explain the principles of the disclosedembodiments. In the drawings:

FIG. 1 illustrates a front perspective view of an example of anexemplary embodiment of a compounding system in accordance with aspectsof the present disclosure.

FIG. 2 illustrates a front perspective view of the compounding system ofFIG. 1 with a transparent housing in accordance with aspects of thepresent disclosure.

FIG. 3 illustrates a side view of the compounding system of FIG. 1 withthe housing removed in accordance with aspects of the presentdisclosure.

FIG. 4 illustrates a perspective view of an exemplary embodiment of apump drive mechanism in accordance with aspects of the presentdisclosure.

FIG. 5 illustrates an exploded view of the pump drive mechanism of FIG.4 in accordance with aspects of the present disclosure.

FIG. 6 illustrates a perspective view of an example of an exemplaryembodiment of a motor mount in accordance with aspects of the presentdisclosure.

FIG. 7 illustrates a rear perspective view of the motor mount of FIG. 6in accordance with aspects of the present disclosure.

FIG. 8 illustrates a perspective view of the motor mount of FIG. 6 inaccordance with aspects of the present disclosure.

FIG. 9 illustrates a perspective view of an exemplary embodiment of acam housing in accordance with aspects of the present disclosure.

FIG. 10 illustrates a rear perspective view of the cam housing of FIG. 9in accordance with aspects of the present disclosure.

FIG. 11 illustrates a rear perspective view of the cam housing of FIG. 9with the gears removed in accordance with aspects of the presentdisclosure.

FIG. 12 illustrates a perspective view of an exemplary embodiment of apump head assembly in accordance with aspects of the present disclosure.

FIG. 13 illustrates a perspective view of the pump head assembly of FIG.12 with an exemplary embodiment of a gripping system and vial puck inaccordance with aspects of the present disclosure.

FIG. 14 illustrates a perspective view of the pump head assembly,gripping system and vial puck of FIG. 13 in accordance with aspects ofthe present disclosure.

FIG. 15 illustrates a rear perspective view of the pump head assembly,gripping system and vial puck of FIG. 13 in accordance with aspects ofthe present disclosure.

FIG. 16 illustrates a perspective view of an exemplary embodiment of agripping system in accordance with aspects of the present disclosure.

FIG. 17 illustrates a rear perspective view of the gripping system ofFIG. 16 in accordance with aspects of the present disclosure.

FIG. 18 illustrates a side perspective view of the gripping system ofFIG. 16 in accordance with aspects of the present disclosure.

FIG. 19 illustrates a top plan view of the gripping system of FIG. 16 inaccordance with aspects of the present disclosure.

FIG. 20 illustrates a top plan view of the gripping system of FIG. 16 inaccordance with aspects of the present disclosure.

FIG. 21 is a flow chart illustrating an exemplary embodiment of thesteps of a process in accordance with aspects of the present disclosure.

FIG. 22 illustrates a perspective view of an exemplary embodiment of acartridge in accordance with aspects of the present disclosure.

FIG. 23 illustrates a perspective view of an exemplary embodiment of acarousel with a cover in accordance with aspects of the presentdisclosure.

FIG. 24 illustrates a front perspective view of another exemplaryembodiment of a compounding system in accordance with aspects of thepresent disclosure.

FIG. 25 illustrates another front perspective view of the compoundingsystem of FIG. 24 in accordance with aspects of the present disclosure.

FIG. 26 illustrates a front perspective view of the compounding systemof FIG. 24 with portions of the housing removed in accordance withaspects of the present disclosure.

FIG. 27 illustrates a rear perspective view of the compounding system ofFIG. 24 with portions of the housing removed in accordance with aspectsof the present disclosure.

FIG. 28 illustrates an exploded perspective view of the compoundingsystem of FIG. 24 in accordance with aspects of the present disclosure.

FIG. 29 illustrates a perspective view of the compounding system of FIG.24 with various components shown in enlarged views for clarity inaccordance with aspects of the present disclosure.

FIG. 30 illustrates a perspective view of a magazine having a pluralityof manifolds disposed in a magazine recess of a pump head assembly inaccordance with aspects of the present disclosure.

FIG. 31 illustrates an exploded perspective view of the magazine andpump head assembly of FIG. 30 in accordance with aspects of the presentdisclosure.

FIG. 32 illustrates a perspective view of a magazine having a pluralityof manifolds in accordance with aspects of the present disclosure.

FIG. 33 illustrates an exploded perspective view of the magazine andmanifolds of FIG. 32 in accordance with aspects of the presentdisclosure.

FIG. 34 illustrates an exploded perspective view of a manifold inaccordance with aspects of the present disclosure.

FIG. 35 illustrates a perspective view of an assembled manifold inaccordance with aspects of the present disclosure.

FIG. 36 illustrates a perspective view of a manifold cap assembly inaccordance with aspects of the present disclosure.

FIG. 37 illustrates an exploded perspective view of a manifold capassembly in accordance with aspects of the present disclosure.

FIG. 38 illustrates a cross-sectional perspective view of a manifold capassembly in accordance with aspects of the present disclosure.

FIG. 39 illustrates an exploded perspective view of a manifold needleguide assembly in accordance with aspects of the present disclosure.

FIG. 40 illustrates an assembled perspective view of a manifold capassembly in accordance with aspects of the present disclosure.

FIG. 41 illustrates a cross-sectional perspective view of a manifold capassembly in accordance with aspects of the present disclosure.

FIG. 42 illustrates an exploded perspective view of a manifold needleassembly in accordance with aspects of the present disclosure.

FIG. 43 illustrates a cross-sectional perspective view of a manifoldneedle assembly in accordance with aspects of the present disclosure.

FIG. 44 illustrates a partially exploded perspective view of a manifoldin accordance with aspects of the present disclosure.

FIG. 45 illustrates a cross-sectional perspective view of a manifold inaccordance with aspects of the present disclosure.

FIG. 46 illustrates a perspective bottom view of a magazine disposedabove a plurality of manifold needle push rods in accordance withaspects of the present disclosure.

FIG. 47 illustrates a bottom perspective view of a magazine with aplurality of needle push rods disposed in rod recesses in acorresponding plurality of manifolds in the magazine in accordance withaspects of the present disclosure.

FIG. 48 illustrates a cross-sectional view of a manifold in a disengagedconfiguration in accordance with aspects of the present disclosure.

FIG. 49 illustrates a cross-sectional view of a manifold in an engagedconfiguration in accordance with aspects of the present disclosure.

FIG. 50 illustrates a cross-sectional side view of a portion of amanifold having multiple sealing members in accordance with aspects ofthe present disclosure.

DETAILED DESCRIPTION

The detailed description set forth below describes variousconfigurations of the subject technology and is not intended torepresent the only configurations in which the subject technology may bepracticed. The detailed description includes specific details for thepurpose of providing a thorough understanding of the subject technology.Accordingly, dimensions may be provided in regard to certain aspects asnon-limiting examples. However, it will be apparent to those skilled inthe art that the subject technology may be practiced without thesespecific details. In some instances, well-known structures andcomponents are shown in block diagram form in order to avoid obscuringthe concepts of the subject technology.

It is to be understood that the present disclosure includes examples ofthe subject technology and does not limit the scope of the appendedclaims. Various aspects of the subject technology will now be disclosedaccording to particular but non-limiting examples. Various embodimentsdescribed in the present disclosure may be carried out in different waysand variations, and in accordance with a desired application orimplementation.

The present system comprises multiple features and technologies that inconjunction form a compounding system that can efficiently reconstitutepharmaceuticals in a sterile environment and deliver the compoundedpharmaceutical to a delivery bag for use on a patient.

FIG. 1 illustrates a compounder system 10 according to an embodiment.FIG. 2 illustrates the system 10 with a transparent outer housing 12 andFIG. 3 illustrates the system with the housing removed. The systemcomprises a carousel assembly 14 that contains up to 10 individualcartridges 16. The carousel 14 can hold more or less cartridges 16 ifdesired. The cartridges 16 are disposable and provide unique fluid pathsbetween a vial 18 containing a powdered drug (or concentrated liquiddrug), multiple diluents, and a receiving container. The cartridges 16may, if desired, also provide a fluid path to a vapor waste container.However, in other embodiments, filtered or unfiltered non-toxic wastemay be vented from the compounder to the environment reducing oreliminating the need for a waste port. Each cartridge contains a pistonpump and valves that control the fluid intake, outtake, and fluid pathselection during the steps of the compounding process as the fluid movesthrough the cartridge and into a receiving container.

The carousel assembly 14 is mounted on the apparatus such that it canrotate to bring different cartridges 16 into alignment with the pumpdrive mechanism 20. The carousel 14 is typically enclosed within ahousing 12 that can be opened in order to replace the carousel 14 with anew carousel 14 after removing a used one. As illustrated, the carousel14 can contain up to 10 cartridges 16, allowing a particular carousel tobe used up to 10 times. In this configuration, each carousel assemblycan support, for example, 10 to 100 receiving containers, depending onthe type of compounding to be performed. For example, for hazardous drugcompounding, a carousel assembly can support compounding to tenreceiving containers. In another example, for non-hazardous drugcompounding such as antibiotic or pain medication compounding, acarousel assembly can support compounding to 100 receiving containers.The housing 12 also includes a star wheel 22 positioned underneath thecarousel 14. The star wheel 22 rotates vials 18 of pharmaceuticals intoposition either in concert with, or separate from, the specificcartridges 16 on the carousel 14. The housing 12 may also include anopening 24 for loading the vials 18 into position on the star wheel 22.

Each one of the cartridges 16 in the carousel 14 is a disposable unitthat includes multiple pathways for the diluent and vapor waste. Eachcartridge 16 is a small, single disposable unit that may also include a“backpack” in which a tube for connection to the receiving container(e.g., an IV bag, a syringe, or an elastomeric bag) may be maintained.Each cartridge 16 also includes a piston pump for moving fluid and vaporthrough the cartridge 16 as well as a duel lumen needle in a housingthat can pierce a vial puck 26 on top of a vial 18 once the vial 18 hasbeen moved into position by the pump drive mechanism 20. For example,the needle may pierce the vial puck 26 via the compressive action of thevial puck 26, which is moved towards the needle. Each cartridge 16 alsoincludes a plurality of ports designed to match up with the needles of aplurality of diluent manifolds. Each cartridge 16 also includes openingsto receive mounting posts and a locking bayonet from the pump headassembly 28. Although a locking bayonet is described herein as anexample, other locking mechanisms may be used to retrieve and lock acartridge to the pump head (e.g., grippers, clamps, or the like mayextend from the pump head). Each cartridge 16 also includes openingsallowing valve actuators from the pump motor mechanism to interact withthe valves on each cartridge 16.

Adjacent the housing 12 that holds the vials 18 and the carousel 14 isan apparatus 30 for holding at least one container 32, such as an IV bag32 as shown in the figures. The IV bag 32 typically has two ports suchas ports 34 and 36. For example, in one implementation, port 34 is anintake port 34 and port 36 is an outlet port 36. The IV bag 32 hangsfrom the holding apparatus 30, which, in one embodiment is a post with ahook as illustrated in FIGS. 1-3 . One or more of the hooks for hangingcontainers such as diluent containers, receiving containers, or wastecontainers may be provided with a weight sensor such as a load cell thatdetects and monitors the weight of a hung container. The holdingapparatus 30 can take any other form necessary to position the IV bag 32or other pharmaceutical container. Once the IV bag 32 is positioned onthe holding apparatus 30, a first tube 38 (a portion of which is shownin FIG. 1 ) is connected from a cartridge 16 on the carousel 14 to theinlet 34 of the IV bag 32. For example, the first tube may be housed ina backpack attached to the cartridge and extended from within thebackpack (e.g., by an operator or automatically) to reach the IV bag 32.A connector 37 such as a Texium® connector may be provided on the end oftube 38 for connecting to inlet 34 of receiving container 32.

On the opposite side of the compounder 10 is an array of holdingapparatuses 40 for holding multiple IV bags 32 or other containers. Inthe illustrated version of the compounder 10, five IV bags 42, 44 arepictured. Three of these bags 42 may contain diluents, such as saline,D5 W or sterile water, although any diluent known in the art may beutilized. An additional bag in the array may be an empty vapor waste bag44 for collecting waste such as potentially hazardous or toxic vaporwaste from the mixing process. An additional bag 44 may be a liquidwaste bag. The liquid waste bag may be configured to receive non-toxicliquid waste such as saline from a receiving container. Liquid waste maybe pumped to the waste bag via dedicated tubing using a mechanical pump.In operation, diluent lines and a vapor waste line from thecorresponding containers 42 and 44 may each be connected to a cartridge16 through a disposable manifold.

The compounding system 10 also includes a specialized vial puck 26designed to attach to multiple types of vials 18. In operation, the vialpuck 26 is placed on top of the vial 18 containing the drug in need ofreconstitution. Once the vial puck 26 is in place, the vial 18 is loadedinto the star wheel 22 of the compounder 10. Mating features on the vialpuck 26 provide proper alignment both while the vial puck 26 is in thestar wheel 22 and when the vial puck 26 is later rotated into positionso that the compounder 10 can remove it from the star wheel 22 forfurther processing.

The pump drive mechanism 20 is illustrated in FIG. 4 , and in anexploded view in FIG. 5 , according to an embodiment. In the embodimentshown in FIGS. 4 and 5 , the pump drive mechanism 20 comprises amultitude of sections. At one end of the pump drive mechanism 20 is therotation housing 46, which holds the drive electronics and includeslocking flanges 94 on its housing 96 for flexible tubing 50 which mayrun from one or more diluent containers and/or waste containers to oneor more corresponding manifolds. The rotation housing 46 is capable ofrotating around its axis to rotate the rest of the pump drive mechanism20. The rotation housing 46 includes bearing ribs 52 on its ends whichallow it to rotate. For example, the pump drive mechanism may beconfigured to rotate through any suitable angle such as up to andincluding 180.degree., or more than 180.degree.

Next to the rotation housing 46 is the motor mount 54, which is shownalone from various angles in FIGS. 6-8 , according to an embodiment. Inthe embodiment shown in FIGS. 4-8 , the cam housing 56, shown in furtherdetails from various angles FIGS. 9-11 , is connected to the motor mount54, which includes cams and gears that control the rotary motion of themotors and the axial motion of the pump drive mechanism 20 as it movesinto position to pick up a cartridge 16 and a vial 18.

The compounder system also includes a diluent magazine (not shown) thatmounts in a slot 60 located on the side of the pump drive mechanism. Thediluent magazine may be a disposable piece configured to receive anynumber of individual diluent manifolds operable as diluent ports. Thediluent manifolds (not shown) may be modular so they can easily andremovably connect to each other, the magazine, and/or connect to thepump drive mechanism 20.

The final portion of the pump drive mechanism 20 is the pump headassembly 28. The pump head assembly 28 includes the vial grasping arms76, the vial lift 78, the pump cartridge grasp 80, the pump pistoneccentric drive shaft 82 with arm 222, the valve actuation mechanisms84, as well as the motors that allow the pump drive mechanism 20 to moveforward and back and to rotate in order to mix the pharmaceutical in thevial 18 once the diluent has been added to it. The compounder 10 mayalso include an input screen 86 such as a touch screen 86 as shown inthe figures to provide data entry by the user and notifications,instructions, and feedback to the user.

The operation of the compounder system 10 will now be generallydescribed in the flowchart illustrated at FIG. 21 , according to anembodiment. In the first step 88, a user inserts a new diluent manifoldmagazine having a plurality of manifolds (e.g., diluent manifolds andwaste manifolds) into the slot 60 on the side of the pump head assembly28. Manifolds may be loaded into the magazine before or after installingthe magazine in the slot 60. The manifolds maintain needles inside thehousing of the manifold until the cartridge 16 is later locked in place.The magazine may contain any number of diluent manifolds and vapor wastemanifolds. In one illustrative system, there may be three diluentmanifolds and one vapor waste manifold. In the next step 92, diluenttubing is connected to corresponding diluent bags. The tubes may berouted through locking flanges on a surface (e.g., the front surface) ofthe compounder frame to hold them in place. For example, in theillustrated embodiment of FIG. 24 , the tubes are held in place withlocking flanges 2402 on the frame of the compounder. Alternatively,other types of clips or locking mechanisms known in the art may be usedto hold the tubes securely in place. In the illustrated embodiment ofFIG. 4 , the additional flanges 94 positioned on the outside housing 96of the pump drive mechanism 20 are provided for securing internal wiringof the compounder. In the next step 98, waste tubing may be connected tothe vapor waste bag 44. In other embodiments, tubing may be pre-coupledbetween the manifolds and associated containers such as diluentcontainers and/or waste containers and the operations of steps 92 and 98may be omitted.

If desired, in the next step 100, a new carousel 14 may be loaded into acarousel mounting station such as a carousel hub of the compoundersystem. The carousel 14 may contain any number of disposable cartridges16 arranged in a generally circular array. In the next step 110, a vialpuck 26 is attached to the top of a vial 18 of a powdered or liquidpharmaceutical for reconstitution and the vial 18 is loaded into thestar wheel 22 under the carousel 14 in the next step 112. Step 110 mayinclude loading multiple vials 18 into multiple vial puck recesses instar wheel 22. After one or more vials are loaded into the star wheel,the vials are rotated into position to enable and initiate scanning ofthe vial label of each vial. In one embodiment, the user will be allowedto load vials into the star wheel until all vial slots are occupied withvials before the scanning is initiated. A sensor may be provided thatdetects the loading of each vial after which a next vial puck recess isrotated into the loading position for the user. Allowing the user toload all vials into the star wheel prior to scanning of the vial labelshelps increase the efficiency of compounding. However, in otherimplementations, scanning of vial labels may be performed after eachvial is loaded or after a subset of vials is loaded. Following thesesetup steps, the next step 114 is for a user to select the appropriatedosage on the input screen.

After the selection on the input screen 86, the compounder 10 beginsoperation 116. The star wheel 22 rotates the vial into alignment 118with the vial grasping calipers 76 of the pump head assembly 28. Thevial puck 26 includes, for example, gears that interface with gearscoupled to a rotational motor that allow the vial 18 to rotate 120 sothat a scanner (e.g., a bar code scanner or one or more cameras) canscan 122 a label on the vial 18. The scanner or camera (and associatedprocessing circuitry) may determine a lot number and an expiration datefor the vial. The lot number and expiration date may be compared withother information such as the current date and/or recall or otherinstructions associated with the lot number. Once the vial 18 is scannedand aligned, in the next step 124 the pump drive mechanism 20 movesforward into position to grip the vial 18 with the calipers 76. Theforward movement also brings the mounting posts 130 and locking bayonet128 on the front of the pump head assembly 28 into matching alignmentwith corresponding openings on a cartridge 16. In the next step 126 thecartridge 16 is locked in place on the pump head assembly 28 with thelocking bayonet 128 and the calipers 76 grip 132 the vial puck 26 on thetop of the vial 18. The calipers 76 then remove 132 the vial 18 from thestar wheel 22 by moving backward, while at the same time pulling 134 thecartridge 16 off of the carousel 14.

In some embodiments, the cartridge 16 includes a backpack that includesa coiled tube. In this embodiment, in step 136 the pump drive mechanism20 tilts the cartridge 16 toward the user to expose the end of the tubeand prompts 138 the user to pull the tube out of the backpack andconnect it to the receiving bag 32. In an alternative embodiment, thetube 38 is exposed on the side of the carousel 14 once the cartridge 16is pulled away from the carousel 14. In another alternative embodiment,the tube 38 is automatically pushed out (e.g., out of the backpack) thusallowing the user to grab onto the connector located at the end of thetube and connect to the receiving container. The system prompts 138 theuser to pull the tube out from the carousel 14 and connect it to theinput 34 of the IV bag 32. Once the tube 38 is connected, in step 140the user may notify the compounder 10 to continue the compoundingprocess by interacting with the input screen 86.

At step 142, the vial 18 is pulled up towards the cartridge 16 so thatone or more needles such as a coaxial dual lumen needle of the cartridge16 pierce the top of the vial puck 26 and enter the interior of the vial18. Although the example of FIG. 21 shows engagement of the needle withthe vial puck after the user attaches the tube from the cartridge to thereceiving container, this is merely illustrative. In another embodiment,steps 138 and 140 may be performed after step 142 such that engagementof the needle with the vial puck occurs before the user attaches thetube from the cartridge to the receiving container.

Diluent is pumped at step 144 into the vial 18 through the cartridge 16and a first needle in the proper dosage. If necessary, a second or thirddiluent may be added to the vial 18 via a second or third diluentmanifold attached to the cartridge 16. Simultaneously, vapor waste ispumped 144 out of the vial 18, through a second needle, through thecartridge 16 and the vapor waste manifold, and into the vapor waste bag44. The valve actuators 84 on the pump head assembly 28 open and closethe valves of the cartridge 16 in order to change the fluid flow pathsas necessary during the process. Once the diluent is pumped into thevial 18, the pump drive mechanism 20 agitates the vial 18 in the nextstep 146 by rotating the vial lift 78 up to, for example 180 degreessuch that the vial 18 is rotated between right-side-up and upside-downpositions. The agitation process may be repeated for as long asnecessary, depending on the type of pharmaceutical that is beingreconstituted. Moreover, different agitation patterns may be useddepending on the type of drugs being reconstituted. For example, forsome drugs, rather than rotating by 180 degrees, a combination offorward-backward, and left-right motion of the pump head may beperformed to generate a swirling agitation of the vial. A plurality ofdefault agitation patterns for specific drugs or other medical fluidsmay be included in the drug library stored in (and/or accessible by) thecompounder control circuitry. Once the agitation step is complete, thepump drive mechanism rotates the vial to an upside down position orother suitable position and holds it in place. In some embodiments, afluid such as a diluent already in the receiving container 32 may bepumped (e.g., through the cartridge or via a separate path) into aliquid waste container to allow room in the receiving container forreceiving the reconstituted medicine.

In the next step 148, the valve actuators 84 reorient the valves of thecartridge and the pumping mechanism of the cartridge 16 is activated topump 150 the reconstituted drug into the receiving bag 32 through theattached tube. Once the drug is pumped into the receiving bag 32, in thenext step 152 the pump drive mechanism 20 clears the tube 38 by eitherpumping filtered air or more diluent through the tube 38 into thereceiving bag 32 after another valve adjustment to ensure that all ofthe reconstituted drug is provided to the receiving bag 32. In somescenarios, a syringe may be used as a receiving container 32. Inscenarios in which a syringe is used as the receiving container 32,following delivery of the reconstituted drug to the syringe, a vacuummay be generated in tube 38 by pump drive mechanism 20 to remove any airor other vapors that may have been pushed into the syringe so that, whenthe syringe is removed from tube 38, the reconstituted drug is read fordelivery to a patient and no air or other unwanted gasses are present inthe syringe.

The system then prompts 154 the user to remove the tube 38 from thereceiving container 32. The user may then insert the connector (e.g., aTexium® or SmartSite® connector) into its slot in the backpack orcarousel and an optical sensor in the pump head may sense the presenceof the connector and automatically retract the tube into either thecarousel or the backpack. The tube is pulled back into either thecarousel 14 or the backpack, depending on which type of system is inuse. In the next step 156, the compounder 10 rotates the vial 18 backinto alignment with the star wheel 22 and releases it. The usedcartridge 16 may also be replaced on the carousel 14. The used cartridgemay be released when a sensor in the pump drive determines that the tubehas been replaced in the cartridge (e.g., by sensing the presence of aconnector such as a Texium® connector at the end of the tube in thebackpack of the cartridge through a window of the cartridge). Thecarousel 14 and/or star wheel 22 then may rotate 158 to a new unusedcartridge 16 and/or a new unused vial 18 and the process may bereplicated for a new drug. In some circumstances (e.g., multiplereconstitutions of the same drug), a single cartridge may be used morethan once with more than one vial.

The cartridges 16 are designed to be disposable, allowing a user toutilize all the cartridges 16 in a given carousel 14 before replacingthe carousel 14. After a cartridge 16 is used, the carousel 14 rotatesto the next cartridge 16, and the system software updates to note thatthe cartridge 16 has been used, thus preventing cross-contamination fromother reconstituted drugs. Each cartridge 16 is designed to contain allthe necessary flow paths, valves, filters and pumps to reconstitute adrug with multiple diluents if necessary, pump the reconstituted druginto the receiving container, pump vapor waste out of the system into awaste container, and perform a final QS step in order to make sure thatthe proper amount of drug and diluent is present in the receivingcontainer. This complete package is made possible by the specific andunique construction of the cartridge 16, its flow paths, and its valveconstruction.

An embodiment of a cartridge 16 is illustrated in FIG. 22 . As shown inFIG. 22 , cartridge 16 may include a cartridge frame 160, a cartridgebezel 164, as well as a piston pump 166, a needle housing 168 and aneedle assembly 170. The cartridge frame 160 provides the main supportfor each cartridge 16 and includes diluent chambers, a vapor wastechamber, a pumping chamber, a hydrophobic vent, an exit port, and/orother features as described hereinafter that can be connected to a tubethat connects to the receiving container 32.

The frame 160 of the cartridge 16 also includes locating features thatallow each cartridge 16 to be removably mounted to the pump headassembly 28. These features include, for example, three openings 198 toreceive mounting posts 130 from the pump head assembly 28, and a keyhole210 that allows a locking bayonet 128 to be inserted therein and turnedto lock the cartridge 16 to the pump head assembly 28 for removal fromthe carousel 14. An outlet port extension 220 may be present in someembodiments. The piston pump 166 is mounted within a chamber with a rod194 positioned within a silicone piston boot. Furthermore, the bezel 164includes openings 228 in which the valves 190 of the sealing membraneare located and be accessed by the valve actuators 84. Bezel 164 mayalso include an opening that facilitates the detection of a connector(e.g., a Texium® or SmartSite® connector) when the user inserts theconnector into the provided slot when compounding is complete. Moreover,the bezel 164 includes openings 230 that allow a fluid manifold to beconnected to the diluent and vapor waste chambers in the cartridge 16.In operation, the needles of the fluid manifold enter through theopenings 230 in the bezel 164 and pierce the sealing membrane to gainfluidic access to the diluent and vapor waste chambers defined in thecartridge 16 between the sealing membrane and the cartridge frame 160.Further details of various embodiments of the cartridge 16 will bediscussed hereinafter.

Referring to FIG. 23 , an exemplary embodiment of a carousel 14 removedfrom the compounder 10 is illustrated, according to an embodiment. Thecarousel 14 of FIG. 23 includes an array of ten cartridges 16 in thisembodiment, but it should be understood that more or fewer cartridges 16can be present on the carousel 14, leaving some of the carousel 14pockets 500 empty, or the frame 510 of the carousel can be designed tohave more or fewer cartridge pockets 500. The carousel 14 also includesa cover 511 that prevents a user from accessing the tubes coupled toeach of the cartridges 16 directly. The cover 511 may be removed ifnecessary to access the backs of the cartridges 16. In the exampleimplementation of FIG. 23 , a connector such as a Texium® attachment 548is disposed adjacent each cartridge 16, the attachment 548 beingattached to the tube 38 that runs from the extension 220 on eachcartridge 16.

FIGS. 24-29 show the compounder 10 according to another embodiment. Asshown in FIG. 24 , holding apparatus 40 may be implemented as anextended arm providing support for mounting devices for each ofcontainers 42 and 44. Holding apparatus 40 and holding apparatus 30 mayeach include one or more sensors such as weight sensors configured toprovide weight measurements for determining whether an appropriateamount of fluid has been added to or removed from a container or toconfirm that fluid is being transferred to and/or from the appropriatecontainer (e.g., that the appropriate diluent is being dispensed). Ascanner 2404 may be provided with which each diluent container and/orthe receiving container can be scanned before and/or after attachment tocompounder 10. As shown in FIG. 24 , a carousel cover 2400 and tubemanagement structures 2402 may also be provided on compounder 10 invarious embodiments. For example, tubes connected between containers 42and/or 44 and corresponding manifolds can each be mounted in a groove oftube management structure 2402 to prevent tangling or catching of thetubes during operation of compounder 10.

As shown in FIG. 25 , an opening 2502 may be provided by which vials 18can be installed in the star wheel. Additionally, an exterior pump 2500may be provided for pumping non-toxic liquid waste from, for example,receiving container 32 to a waste container 44 (e.g., for pumping adesired amount of saline out of receiving container 32 quickly andwithout passing the liquid waste through a cartridge and/or otherportions of the compounder).

A fluidics module 2504 may be provided that includes several containermounts 2506. Container mounts 2506 may be used for hanging diluent andwaste containers and may include sensor circuitry for sensing when acontainer has been hung and/or sensing the weight of the container. Inthis way, the operation of compounder 10 can be monitored to ensure thatthe correct diluent contain has been scanned and hung in the correctlocation and that the waste is being provided in an expected amount tothe appropriate waste container.

As shown in FIG. 26 , pump 2500 and display 86 may be mounted to achassis 2600. Pump drive 20 may be mounted partially within the chassis2600 with pump head assembly 28 extending from the chassis to a positionwhich allows the pump head assembly to rotate (e.g., to turn over oragitate a vial). Carousel 14 is also shown in FIG. 26 without anycartridges mounted therein so that cartridge mounting recesses 500 canbe seen.

Star wheel 22 (sometimes referred to herein as a vial tray) is shown inFIG. 26 with several empty vial puck recesses 2604. Vial tray 22 may berotated and an actuating door 2608 may be opened to facilitate loadingof vials 18 into the vial puck recesses 2604 in vial tray 22. In someembodiments, door 2608 may be closed before rotation of vial tray 22 toensure that the operator's fingers are not in danger of injury from therotating tray. However, this is merely illustrative. In otherembodiments a sensor such as sensor 2650 (e.g., a light curtain) may beprovided instead of (or in addition to) door 2608 to sense the presenceof an operator in the vicinity of tray 22 and prevent rotation of thetray if the operator or any other obstruction is detected.

Similarly, a lid may be provided for carousel 14 to preventcontamination of cartridges 16 loaded therein, and to prevent injury toan operator due to rotation of the carousel. A lid sensor (not shown)may also be provided to detect the position (e.g., an open position or aclosed position) of the lid. Rotation of carousel 14 may be prevented ifthe lid is not detected in a closed position by the lid sensor.

Each vial 18 that is inserted may be detected using a sensor such assensor 2652 (e.g., a load sensor or an optical sensor) when placed in avial puck recess 2604. When detected, the inserted vial may be moved toa scanning position by rotating vial tray 22 and then the inserted vial18 may be rotated within its position in vial tray 22 using a vialrotation motor 2602 to allow the vial label to be scanned.

A reverse perspective view of compounder 10 is shown in FIG. 27 in whichscanning components can be seen. In particular, a camera 2700 is mountedin an opening in chassis 2600 and configured to view a vial 18 in ascanning position. Motor 2602 may rotate vial 18 through one or morefull rotations so that camera 2700 can capture images of the vial label.In some embodiments, an illumination device 2702 (e.g., a light-emittingdiode or other light source) may be provided that illuminates vial 18for imaging with camera 2700.

As shown in FIG. 27 one or more gears 2704 coupled to motor 2602 may beprovided that engage corresponding gears on a vial puck 26 to which avial 18 is attached at the scanning position. The vial tray 22 may berotated so that the vial puck gears engage the rotation motor gears sothat when the motor 2602 is operated the vial 18 is rotated.

FIG. 27 also shows how a magazine 2706 containing one or more manifoldsmay be mounted in a recess in pump head assembly 28. A magazine slot inmagazine 2706 for the vapor waste manifold may be keyed to preventaccidental connection of a diluent manifold in that slot (or a wastemanifold in a diluent slot in the magazine). Other diluent slots inmagazine 2706 may have a common geometry and thus any diluent manifoldcan fit in the magazine diluent slots. One or more manifold sensors suchas manifold sensor 2750 (e.g., an optical sensor) may be provided in themanifold recess in pump head assembly 28. Manifold sensor 2750 may beconfigured to detect the presence (or absence) of a manifold in amanifold recess (slot) in magazine 2706 to ensure that an appropriatemanifold (e.g., a diluent manifold or waste manifold) is loaded at theexpected position for compounding operations. In this way, the pump headmay detect a manifold presence. The pump head and/or manifold sensorsmay communicate with the diluent load sensors to ensure properpositioning of the diluent manifolds. Various operational components2708 such as valve actuators, needle actuators, mounting posts, alocking bayonet, and a drive pin (e.g., as described above in connectionwith FIG. 4 ) can also be seen extended from pump head assembly 28 whichare configured to secure and operate a pump cartridge 16.

An exploded view of various components of compounder 10 is shown in FIG.28 . Components discussed above such as display 86, pump 2500, dosehanger 30, fluidics module 2504, pump drive 20 with pump head assembly28, camera 2700, and lighting device 2702 are shown. Additionalcomponents such as a chassis base 2810 and chassis housing 2812 ofchassis 2600 are also shown in FIG. 28 . A rear panel 2802 having anelectronics assembly 2803 can be mounted to chassis housing 12 and pumpdrive 20 may be seated in an opening 2808 in chassis housing 2812 thatallows pump head assembly 28 to protrude from chassis housing 2812.Processing circuitry for managing operations of compounder system 10 maybe included in electronics assembly 2803.

A vial tray and carousel drive assembly 2800 is also shown in whichactuating door 2608 and a carousel hub 2814 can be seen. Carousel 14 maybe placed onto carousel hub and rotated by vial tray and carousel driveassembly 2800 operating to rotate hub 2814 to move a selected cartridgein the carousel into position to be retrieved and operated by pump drive20. Vial tray and carousel drive assembly 2800 may include separatedrive assemblies for the vial tray and for the carousel such that vialtray 22 and carousel 14 may be rotated independently.

FIG. 29 shows another perspective view of compounder 10 highlighting thelocations of various particular components such as the carousel 14 withcartridges 16 mounted therein, a cartridge 16 having a backpack 2900, avial puck 26 for mounting vials 18, and pump head assembly 28 with adiluent magazine 2706 containing a plurality of manifolds 2906 inaccordance with an embodiment. Further features of the diluent magazine2904 and manifolds 2906 will be described hereinafter in connection withFIGS. 30-50 .

Turning now to FIG. 30 , pump head assembly 28 is shown according to anembodiment. As shown in FIG. 30 , a plurality of manifolds 2906 may bedisposed in a magazine 2706 that is shaped and sized to be received inthe slot 60 of the pump head assembly. Magazine 2706 may include a pairof extended wings 3000 that are squeezable by a user to remove andinstall the magazine in the slot. In the example of FIG. 30 , aplurality of openings 3002 are also shown in the pump head assemblythrough which various other pump control components such as components2708 of FIG. 27 can extend to operate other portions of compoundersystem 10 (e.g., to controllably pump fluid through a cartridge 16).

FIG. 31 is an exploded view of the assembly of FIG. 30 in which aplurality of needle push rods 3104 can be seen extended from pump headassembly 28 into the slot 60. Each needle push rod 3104 may be extendedand/or retracted by the pump drive assembly to actuate a needle assemblyin a corresponding manifold 2906. Magazine 2706 may include one or morealignment features 3110 each having a shape, size, and position thatcorresponds to associated alignment features 3108 in slot 60 that guidemagazine 2706 into the slot and prevent incorrect insertion of themagazine in the slot (e.g., by providing a mechanical barrier toinsertion if the magazine is in a reverse orientation). Alignmentfeatures 3110 may be protrusions on the body of the magazine thatcorrespond to recesses 3108 in slot 60. However, this is merelyillustrative and any combination of protrusions and/or recesses onmagazine 2706 and slot 60 may be provided that guide magazine 2706 intothe slot and prevent incorrect insertion of the magazine in the slot.

Magazine 2706 may include a snap feature 3109 configured to engage acorresponding snap feature 3106 in slot 60 to secure magazine 2706 inslot 60 during compounding operations. As illustrated, snap feature 3109is implemented as a protrusion on the body of the magazine thatcorresponds to a recess 3106 in slot 60. However, this is merelyillustrative. In other embodiments, snap features 3109 and 3106 mayinclude a protrusion within slot 60 that corresponds to a recess inmagazine 2706. As shown in FIG. 31 , slot 60 may have a relativelysmooth surface that can be easily wiped clean. When magazine 2706 isinstalled in slot 60, push rods 3104 may slide into corresponding slotsin manifolds 2906 as will be discussed in further detail hereinafter.

An enlarged perspective view of magazine 2706 and manifolds 2906 isshown in FIG. 32 in which it can be seen that magazine 2706 may beconfigured to hold, in one embodiment, three diluent manifolds 2906 anda waste manifold 2906A. As shown, waste manifold 2906A may have adifferent shape than the diluent manifolds to ensure that the wastemanifold can only be installed at a particular position in the magazine.During compounding operations, a needle may be extended from a selectedone of the diluent manifolds into a port in a pump cartridge to allowdiluent from a corresponding container 42 to be pumped through cartridgeto a vial 18 or to a receiving container 32. A needle may also beextended from waste manifold 2906A to a waste port in the pump cartridgeto provide a sealed fluid path for vapor and/or liquid waste from thecartridge to a waste container 44.

As shown in the exploded perspective view of FIG. 33 , each manifold2906 may include an opening 3304 configured to receive tubing that runsfrom the manifold to a corresponding diluent or waste container 42, 44.Each manifold 2906 may also include a cap assembly that includes a cap3308 and a compressible membrane 3310 that extends through an opening inthe cap to form a sealing member. The compressible membrane 3310 may bepressed against a membrane of the cartridge in the corresponding port ofthe cartridge and the needle may be extended through the membrane 3310and the membrane of the cartridge to provide a sealed fluid pathway fromcontainers 42 and 44 into an appropriate port in the cartridge forcompounding operations.

Each manifold 2906 may include multiple components such as the capassembly, a manifold housing 3303, and a needle guide assembly 3306. Aneedle assembly may be disposed within the needle guide assembly 3306and the housing 3303 as will be described in further detail hereinafter.Each manifold 2906 may be placed into a corresponding recess 3302 onmagazine 2706. As shown in FIG. 33 , magazine housing 3300 may includealignment features within each recess 3302 that guide manifolds 2906into the appropriate slot 3302. For example, each housing 3303 mayinclude rails 3314 that slide over a corresponding alignment structurein a corresponding recess 3302 in magazine 2706. As shown, wastemanifold 2906 a may have rails 3314A that are spaced relatively furtherapart that the rails 3314 of the diluent manifolds to prevent the wastemanifold from being installed in the magazine in the wrong position.

FIG. 34 shows a partially exploded view of a manifold 2906 showingfurther details of the manifold housing 3303 and needle guide assembly3306. As shown, needle guide 3306 may include guide ribs 3410 that alignthe needle guide assembly 3306 into a rear portion 3404 of housing 3303until a snap feature 3408 engages in opening 3406 in the housing tosecure the needle guide assembly in the housing.

Housing 3303 may include one or more alignment features such asprotrusion 3411 that help align and secure the manifold in the magazine.Housing 3303 may also include a cap mount portion 3400. Cap 3308 may beconfigured to snap onto cap mount portion 3400 to secure cap 3308 ontohousing 3303 such that a fluid pathway 3402 is sealed by membrane 3310.Fluid pathway 3402 may be fluidly coupled to opening 3304. FIG. 35 showsan assembled perspective view of manifold 2906 with cap 3308 disposed oncap mount portion 3400 and with snap feature 3408 disposed in opening3406.

Further details of cap assembly 3600 are shown in FIGS. 36-38 . FIG. 36shows a perspective view of cap assembly 3600 showing how membrane 3310may be located within cap 3308 such that a portion of the membrane 3310protrudes through an opening in cap 3308. The opening 3702 in cap 3308is shown in FIG. 37 . As shown in FIG. 37 membrane 3310 may include abase portion 3701 and a protruding portion 3700 that form a sealingmember for cap assembly 3600. Opening 3702 in cap 3308 may have adiameter that is smaller than the diameter of protruding portion 3700 sothat protruding portion 3700 is compressed (e.g., by 10 percentradially) by an edge of opening 3702 when membrane 3701 is pressed intocap 3308. By compressing protruding portion 3700, a needle that passesthrough membrane 3310 to allow fluid to flow through membrane 3310 maybe wiped by membrane 3310 when the needle is retracted from the membrane3310. In this way, manifold 2906 may provide a drip-free, sealedcoupling between diluent and/or waste containers 42 and 44 and cartridge16 when needed.

FIG. 38 is a cross-sectional view of cap assembly 3600 showing howcontact points 3800 between cap 3308 and compressible membrane 3310 canbear against membrane 3310 to radially compress the membrane. As shownin FIG. 38 base portion 3701 may include a recess 3802 for receiving thetip of a needle of the manifold as will be discussed in further detailhereinafter.

Further details of needle guide assembly 3306 are shown in FIGS. 39-41 .FIG. 39 shows an exploded perspective view of assembly 3306 showing howassembly 3306 may include an inner housing member 3900 and an inner sealmember 3902. Inner seal member 3902 may include an opening 3904configured to receive a needle. As shown, inner housing 3900 may includea mounting structure 3906 including a plurality of ribs 3908 configuredto hold inner seal 3902 within inner housing 3900. FIG. 40 shows anassembled view of needle guide assembly 3306.

FIG. 41 shows a cross-sectional view of needle guide assembly 3306showing how inner housing 3900 may include an internal bore 4100 that isfluidly connected to opening 3904. Inner bore 4100 and opening 3904 maycooperate to guide a needle assembly having a needle that extendsthrough opening 3904. Inner housing 3900 may include a cutout 4102 on abottom rear side that accommodates access of a needle push rod to theneedle assembly.

FIGS. 42 and 43 show a needle assembly that may be at least partiallydisposed within needle guide assembly 3306. As shown in FIG. 42 , needleassembly 4200 may include a needle 4202 and a needle housing 4204.Needle housing 4204 may be insert molded onto the needle in someembodiments. As shown, needle 4202 may include openings such as forwardopenings 4208 disposed proximal to the tip of the needle and one or morerear openings such as opening 4210.

Needle housing 4204 may include an opening 4206 for receiving a rear endof needle 4202 and a slot 4212. Slot 4212 may be configured to receiveone of needle push rods 3104 (FIG. 31 ) when a magazine with themanifold is inserted in slot 60 of pump head assembly 28.

FIG. 43 is a cross sectional view of needle assembly 4200 showing howneedle 4202 may include a central bore 4300. Openings 4208 and 4210 maybe arranged to allow fluid to flow through bore 4300 of needle 4202.Needle housing 4204 may include a base member 4302 that bears against arear end of needle 4202. A push rod disposed in slot 4202 may push andpull needle 4202 via needle housing 4204 such that the needle assemblyis guided within needle guide assembly 3306 when the push rod isactuated to actuate the needle.

FIG. 44 is a partially exploded perspective view of manifold 2906 withneedle assembly 4200 aligned for insertion into needle guide assembly3306. FIG. 45 is a cross-sectional perspective view of manifold 2906with needle assembly 4200 disposed therein. As shown in FIG. 45 , needlehousing 4204 may be located within central bore 4100 of inner housingand needle 4202 may extend from needle housing 3204 through central bore4100 and through the opening in sealing member 3902 into a coalignedbore 4502 in manifold housing 3303.

Slot 4212 of needle housing 4204 may be disposed over cutout 4102 sothat a needle push rod may be seated in slot 4212 for actuating needle4202 through membrane 3310 to form a closed fluid path via needle 4202(e.g., via openings 4208 and 4210 and central bore 4300) throughmembrane 3310. Slot 4212 may be formed in a portion of inner housing3900 that extends from a beyond a rear portion 4500 of manifold housing3303.

Manifold housing 3303 may include an opening 4504 between bore 4502 andopening 3304. In the configuration shown in FIG. 45 , inner seal 3902and membrane 3310 prevent any fluid from flowing to or from opening 3304via bore 4502. However, if needle 4202 is actuated forward such thatopenings 4208 and 4210 are disposed on opposing sides of membrane 3310,then bore 4300 of needle 4202 forms a closed fluid pathway from opening3304 (e.g., from a diluent container coupled by tubing to opening 3304)through needle 4202 and through membrane 3310 (e.g., into a pumpcartridge 16).

FIG. 46 is a bottom perspective view of magazine 2706 in which aplurality of manifolds 2906 are mounted. As shown in FIG. 46 , eachneedle push rod 3104 may include an engagement feature 4600 configuredto engage in slot 4212 of a corresponding manifold 2906. Guide openings4602 may also be formed in a bottom surface of magazine 2706 thatreceive protrusions 3411 of manifold housing to help guide manifolds2906 into the appropriate position in the appropriate recess in magazine2706 and also help ensure that the manifolds remain upright in therecess. FIG. 47 shows needle push rods 3104 each engaged with a needlehousing 4204 of a corresponding manifold. Pump drive assembly 20 may beconfigured to actuate one or more push rods 3104 to actuate acorresponding needle in a corresponding manifold.

Because needle 4202 can be extended through membrane 3310 or retractedto seal membrane 3310, each manifold 2906 can have a disengaged positionand an engaged position. In the disengaged position, needle 4202 iscompletely contained within manifold 2906 and fluid is prevented fromflowing through manifold 2906. In the engaged position, needle 4202 isextended through membrane 3310 with openings on opposing sides ofmembrane 3310 that allow fluid to flow through the central bore of theneedle and thus through the manifold. In this way, a drip-free manifoldmay be provided to selectively allow fluid to flow (e.g., from a diluentcontainer to a pump cartridge or from a pump cartridge to a wastecontainer).

FIG. 48 is a cross-sectional view of manifold 2906 in the disengagedposition. As shown in FIG. 48 , in the disengaged position, bothopenings 4208 and 4210 of needle 4202 are located within bore 4502 ofmanifold housing 3303 and membrane 3310 is sealed. Thus, in thedisengaged position, fluid from tubing 4819 (e.g., tubing such as tubing50 that is fluidly coupled to outlet port 36 of a diluent container) isprevented from flowing through manifold 2906. Similarly, in thedisengaged position, fluid and vapor are prevented from flowing intomanifold 2906 through membrane 3310.

As shown in FIG. 48 , central bore 4100 and coaligned bore 4502 may eachhave a ramped surface at a forward end that forms a needle guide (seeneedle guides 4806 and 4802 respectively) that ensure proper positioningof needle 4202 when the needle assembly is inserted into manifold 2906.As shown, manifold housing 3303 and membrane 3310 may form a seal 4804that prevents fluid or vapors from flowing around membrane 3310 into orout of manifold 2906 at the forward end. Similarly, manifold housing3303 and sealing member 3902 may form a seal 4812 that prevents fluid orvapors from flowing around member 3902 into or out of manifold 2906 atthe rear end (e.g., between housing 3303 and internal bore 4100 ofneedle guide housing 3900). Guide ribs 4810 may also be provided oninternal housing 3900 of needle guide assembly 3306 that guide needlehousing 4204 within internal housing 3900. Snap features 4800 and 4808that respectively secure cap 3308 and needle guide assembly 3306 withinmanifold housing 3303 are also shown in FIG. 48 .

FIG. 49 is a cross-sectional view of manifold 2906 in the engagedposition. As shown in FIG. 49 , in the engaged position, push rod 3104has moved needle assembly 4200 forward such that needle 4202 haspenetrated through membrane 3310 such that openings 4208 and 4210 ofneedle 4202 are disposed on opposing sides of membrane 3310. In thisconfiguration, fluid can flow from tubing 4819 (e.g., from a diluentcontainer) into opening 3304, through bore 4502, into needle 4202through opening 4210 and out of opening 4208 into, for example, a pumpcartridge 16. In other example, waste such as vapor waste or liquidwaste from a compounding operation can flow from cartridge 16 intoneedle 4202 through opening 4208, out of opening 4210 into bore 4502 andthrough opening 3304 into tubing 4819 to, for example, a wastecontainer.

As shown in FIG. 49 , a forward surface of membrane 3310 may be pressedagainst a compliant membrane 162 of cartridge 16 within opening 230corresponding to a diluent port or waste port of the cartridge 16.Needle 4202 may be extended (e.g., using push rod 3104) through bothmembrane 3310 and membrane 162 to form a closed fluid path betweenmanifold 2906 and a fluid pathway 4904 of cartridge 16.

In operation, a magazine having one or more manifolds such as threediluent manifolds and a waste manifold may be rotated by pump headassembly 28 to align with corresponding ports formed by openings 230 ina pump cartridge. A needle from a selected one of the diluent manifoldsmay be extended into the cartridge to provide a fluid path from adiluent container into the cartridge. The pump drive assembly may thenoperate a piston and/or one or more valves of the cartridge to pump thediluent into, for example a vial of a powdered or concentrated liquiddrug to reconstitute the drug in the vial. The pump drive assembly maythen operate the piston and one or more valves of the pump cartridge topump the reconstituted drug into a receiving container.

A needle in the waste manifold may also be extended into the cartridgeto provide a fluid path from a cartridge to a vapor and/or liquid wastecontainer. The piston and one or more valves of the cartridge may alsobe operated to pump vapor and/or liquid waste from the pump cartridge,through the waste manifold, and into a waste container. After theappropriate amount of a drug has been provided into the receivingcontainer, the needles of the manifolds may be retracted using the pushrods into the respective manifolds. As the needles are retracted, thesealing members of the cartridge and the manifold may effectively wipethe needle of any liquid so that, when the cartridge and the manifoldare separated, no liquid waste is formed outside of the closed system ofthe cartridge or the closed system of the manifold.

Manifolds for the diluent and waste containers may be provided in anintegrated assembly with the corresponding diluent and waste containers.Membrane 3310 of a manifold 2906 may have a resiliency that allows themembrane to be pierced by a manifold needle multiple times (e.g., up to50 times) without compromising the seal formed by the membrane 3310 whenthe needle is retracted into the manifold. In this way, a diluentcontainer or waste container can be used for compounding with multiplecartridges, with drugs from multiple vials and/or into multiplecontainers.

FIG. 50 shows a cross-sectional view of a portion of manifold 2906 in animplementation with three sealing members. As shown in FIG. 50 , sealingmember 3310 may be formed from an outer sealing member 5000, anintermediate sealing member 5002, and an inner sealing member 5004.Intermediate sealing member 5002 may be disposed between outer sealingmember 5000 and an inner sealing member 5004.

As shown in FIG. 50 , outer sealing member 5000 may, similarly tosealing member 3310 in FIG. 38 (for example), include a portion thatextends through an opening within cap 3308 of manifold 2906. The centralopening in which outer sealing member 5000 is disposed may be smallerthan sealing member 5000 so that sealing member 5000 is compressed by asurface of cap 3308 when installed in cap 3308 (e.g., radiallycompressed by up to or approximately 10% to provide a wiping effect on aneedle that is inserted or removed from sealing member 5000).

Outer sealing member 5000 may include a recess 5006 in a surfaceadjacent to intermediate sealing member 5002. Intermediate sealingmember 5002 may also include a recess 5208 on an interior surfaceadjacent to inner sealing member 5004. Providing multiple sealingmembers such as the three sealing members (i.e., member 5000, member5002, and member 5004) may provide an enhanced wiping of needle 4202 toprovide an improved dry disconnect in comparison with implementationswith a single sealing member. However, this is merely illustrative. Invarious embodiments, one, two, three, or more than three sealing membersfor each manifold may be provided. Similarly, interstitial spaces formedfrom recesses 5006 and 5008 may further increase the efficiency of thewiping of needle 4202, however, in various embodiments, sealing membersmay be provided with or without recesses 5008 and/or 5008.

The subject technology is illustrated, for example, according to variousaspects described above. Various examples of these aspects are describedas numbered concepts or clauses (1, 2, 3, etc.) for convenience. Theseconcepts or clauses are provided as examples and do not limit thesubject technology. It is noted that any of the dependent concepts maybe combined in any combination with each other or one or more otherindependent concepts, to form an independent concept. The following is anon-limiting summary of some concepts presented herein:

Concept 1. A manifold, comprising: a housing; a cap assembly having afirst sealing member; a needle guide assembly having a second sealingmember; and a needle assembly having a needle with a central bore, afirst opening, and a second opening, wherein the needle assembly isextendible from a disengaged position in which the first and secondopenings are both disposed on a common side of the first sealing memberbetween the first and second sealing members and an engaged position inwhich the first and second openings are disposed on opposing sides ofthe first sealing member.

Concept 2. The manifold of Concept 1 or any other Concept, wherein thehousing comprises an opening configured to receive tubing from acontainer, and wherein, in the engaged position, the needle assembly isconfigured to allow flow of a liquid or a vapor through the opening inthe housing, through the first and second openings in the needle, andthrough the central bore of the needle.

Concept 3. The manifold of Concept 2 or any other Concept, wherein theneedle guide assembly comprises an inner housing having a central bore,and wherein the needle assembly comprises a needle housing configured toslide within the central bore of the inner housing.

Concept 4. The manifold of Concept 3 or any other Concept, wherein theneedle housing comprises a slot configured to receive a needle push rodfor actuating the needle assembly between the disengaged and engagedpositions.

Concept 5. The manifold of Concept 4 or any other Concept, wherein theinner housing of the needle guide assembly comprises a cutout configuredto provide access to the slot of the needle housing when the needlehousing is in the disengaged position.

Concept 6. The manifold of Concept 5 or any other Concept, wherein theinner housing of the needle guide assembly comprises at least one snapfeature configured to engage with the housing of the manifold to securethe needle guide assembly within the housing.

Concept 7. The manifold of Concept 2 or any other Concept, wherein thecap assembly further comprises a cap, wherein the first sealing memberis disposed within the cap and wherein the cap is configured to snaponto the housing.

Concept 8. The manifold of Concept 7 or any other Concept, wherein thecap comprises an opening, wherein the first sealing member comprises amembrane having an extended portion, and wherein an edge of the openingin the cap bears against the extended portion of the first sealingmember to radially compress the first sealing member.

Concept 9. The manifold of Concept 8 or any other Concept, wherein theextended portion of the first sealing member has a diameter and whereinthe edge of the opening bears against the extended portion of the firstsealing member to radially compress the first sealing member byapproximately 10 percent of the diameter.

Concept 10. A compounder system, comprising: a pump head assembly havinga recess and a plurality of operational mechanisms; a magazineconfigured to be received in the recess; a manifold configured to bereceived in the magazine; a container fluidly coupled to the manifold;and a pump cartridge configured to be operated by the plurality ofoperational mechanisms of the pump drive to pump a fluid from thecontainer through the manifold into the pump cartridge, wherein themanifold comprises a needle assembly having a disengaged configurationin which the needle assembly is completely disposed within the manifoldsuch that the manifold prevents flow of the fluid and an engagedconfiguration in which the needle of the needle assembly extends fromthe manifold into the pump cartridge such that the needle forms aportion of a sealed fluid pathway from the container to the pumpcartridge.

Concept 11. The compounder system of Concept 10 or any other Concept,wherein the pump cartridge comprises: a frame having an opening; and acompliant membrane disposed adjacent the frame, wherein, in the engagedconfiguration, the needle extends through the opening in the frame andthrough the compliant membrane into the pump cartridge.

Concept 12. The compounder system of Concept 11 or any other Concept,wherein the manifold further comprises a cap assembly having a sealingmember configured to be pressed against the compliant membrane of thepump cartridge, and wherein, in the engaged configuration, the needleextends through the sealing member of the cap assembly of the manifoldand through the opening in the frame and through the compliant membraneinto the pump cartridge.

Concept 13. The compounder system of Concept 10 or any other Concept,wherein the magazine comprises a plurality of recesses configured toreceive a plurality of manifolds.

Concept 14. The compounder system of Concept 13 or any other Concept,wherein each recess comprises alignment features configured to guide acorresponding manifold into the recess and prevent incorrectinstallation of any manifold in the recess.

Concept 15. The compounder system of Concept 14 or any other Concept,wherein the plurality of recess comprises a plurality of diluentmanifold recesses and at least one waste manifold recess, wherein thealignment features in the diluent manifold recesses are different fromthe alignment features in the waste manifold recess.

Concept 16. The compounder system of Concept 14 or any other Concept,wherein the magazine further comprises a pair of squeezable gripsconfigured to facilitate installation and removal of the magazine fromthe recess of the pump head assembly.

Concept 17. A method, comprising: providing a plurality of manifolds ina magazine, each manifold fluidly coupled by tubing to a container;providing the magazine in a recess of a pump head assembly of acompounder system; aligning the plurality of manifolds with acorresponding plurality of ports in a pump cartridge; and extending aneedle from at least one of the manifolds into the corresponding port inthe pump cartridge to create a fluid pathway between the container thatis fluidly coupled to that manifold and the pump cartridge.

Concept 18. The method of Concept 17 or any other Concept, whereinextending the needle comprises extending the needle through a sealingmember of the manifold into the pump cartridge.

Concept 19. The method of Concept 18 or any other Concept, whereinproviding the magazine in the recess comprises inserting the magazineinto the recess such that a plurality of needle push rods of the pumphead assembly are each engaged in a slot of a corresponding one of themanifolds, and wherein extending the needle comprises extending theneedle using a selected one of the needle push rods.

Concept 20. The method of Concept 17 or any other Concept, whereinaligning the plurality of manifolds with the corresponding plurality ofports in the pump cartridge comprises: rotating the magazine with thepump head assembly; and removing the pump cartridge from a carousel ofcartridges to a position adjacent the pump head assembly.

The present disclosure is provided to enable any person skilled in theart to practice the various aspects described herein. The disclosureprovides various examples of the subject technology, and the subjecttechnology is not limited to these examples. Various modifications tothese aspects will be readily apparent to those skilled in the art, andthe generic principles defined herein may be applied to other aspects.

One or more aspects or features of the subject matter described hereinmay be realized in digital electronic circuitry, integrated circuitry,specially designed ASICs (application specific integrated circuits),computer hardware, firmware, software, and/or combinations thereof. Forexample, infusion pump systems disclosed herein may include anelectronic system with one or more processors embedded therein orcoupled thereto. Such an electronic system may include various types ofcomputer readable media and interfaces for various other types ofcomputer readable media. Electronic system may include a bus, processingunit(s), a system memory, a read-only memory (ROM), a permanent storagedevice, an input device interface, an output device interface, and anetwork interface, for example.

Bus may collectively represent all system, peripheral, and chipset busesthat communicatively connect the numerous internal devices of electronicsystem of an infusion pump system. For instance, bus may communicativelyconnect processing unit(s) with ROM, system memory, and permanentstorage device. From these various memory units, processing unit(s) mayretrieve instructions to execute and data to process in order to executevarious processes. The processing unit(s) can be a single processor or amulti-core processor in different implementations.

A reference to an element in the singular is not intended to mean “oneand only one” unless specifically so stated, but rather “one or more.”Unless specifically stated otherwise, the term “some” refers to one ormore. Pronouns in the masculine (e.g., his) include the feminine andneuter gender (e.g., her and its) and vice versa. Headings andsubheadings, if any, are used for convenience only and do not limit theinvention.

The word “exemplary” is used herein to mean “serving as an example orillustration.” Any aspect or design described herein as “exemplary” isnot necessarily to be construed as preferred or advantageous over otheraspects or designs. In one aspect, various alternative configurationsand operations described herein may be considered to be at leastequivalent.

As used herein, the phrase “at least one of” preceding a series ofitems, with the term “or” to separate any of the items, modifies thelist as a whole, rather than each item of the list. The phrase “at leastone of” does not require selection of at least one item; rather, thephrase allows a meaning that includes at least one of any one of theitems, and/or at least one of any combination of the items, and/or atleast one of each of the items. By way of example, the phrase “at leastone of A, B, or C” may refer to: only A, only B, or only C; or anycombination of A, B, and C.

A phrase such as an “aspect” does not imply that such aspect isessential to the subject technology or that such aspect applies to allconfigurations of the subject technology. A disclosure relating to anaspect may apply to all configurations, or one or more configurations.An aspect may provide one or more examples. A phrase such as an aspectmay refer to one or more aspects and vice versa. A phrase such as an“embodiment” does not imply that such embodiment is essential to thesubject technology or that such embodiment applies to all configurationsof the subject technology. A disclosure relating to an embodiment mayapply to all embodiments, or one or more embodiments. An embodiment mayprovide one or more examples. A phrase such an embodiment may refer toone or more embodiments and vice versa. A phrase such as a“configuration” does not imply that such configuration is essential tothe subject technology or that such configuration applies to allconfigurations of the subject technology. A disclosure relating to aconfiguration may apply to all configurations, or one or moreconfigurations. A configuration may provide one or more examples. Aphrase such a configuration may refer to one or more configurations andvice versa.

In one aspect, unless otherwise stated, all measurements, values,ratings, positions, magnitudes, sizes, and other specifications that areset forth in this specification, including in the claims that follow,are approximate, not exact. In one aspect, they are intended to have areasonable range that is consistent with the functions to which theyrelate and with what is customary in the art to which they pertain.

It is understood that the specific order or hierarchy of steps, oroperations in the processes or methods disclosed are illustrations ofexemplary approaches. Based upon implementation preferences orscenarios, it is understood that the specific order or hierarchy ofsteps, operations or processes may be rearranged. Some of the steps,operations or processes may be performed simultaneously. In someimplementation preferences or scenarios, certain operations may or maynot be performed. Some or all of the steps, operations, or processes maybe performed automatically, without the intervention of a user. Theaccompanying method claims present elements of the various steps,operations or processes in a sample order, and are not meant to belimited to the specific order or hierarchy presented.

All structural and functional equivalents to the elements of the variousaspects described throughout this disclosure that are known or latercome to be known to those of ordinary skill in the art are expresslyincorporated herein by reference and are intended to be encompassed bythe claims. Moreover, nothing disclosed herein is intended to bededicated to the public regardless of whether such disclosure isexplicitly recited in the claims. No claim element is to be construedunder the provisions of 35 U. S.C. .sctn. 112 (f) unless the element isexpressly recited using the phrase “means for” or, in the case of amethod claim, the element is recited using the phrase “step for.”Furthermore, to the extent that the term “include,” “have,” or the likeis used, such term is intended to be inclusive in a manner similar tothe term “comprise” as “comprise” is interpreted when employed as atransitional word in a claim.

The Title, Background, Summary, Brief Description of the Drawings andAbstract of the disclosure are hereby incorporated into the disclosureand are provided as illustrative examples of the disclosure, not asrestrictive descriptions. It is submitted with the understanding thatthey will not be used to limit the scope or meaning of the claims. Inaddition, in the Detailed Description, it can be seen that thedescription provides illustrative examples and the various features aregrouped together in various embodiments for the purpose of streamliningthe disclosure. This method of disclosure is not to be interpreted asreflecting an intention that the claimed subject matter requires morefeatures than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive subject matter lies in less than allfeatures of a single disclosed configuration or operation. The followingclaims are hereby incorporated into the Detailed Description, with eachclaim standing on its own as a separately claimed subject matter.

The claims are not intended to be limited to the aspects describedherein, but is to be accorded the full scope consistent with thelanguage claims and to encompass all legal equivalents. Notwithstanding,none of the claims are intended to embrace subject matter that fails tosatisfy the requirement of 35 U.S.C. .sctn. 101, 102, or 103, nor shouldthey be interpreted in such a way.

The invention claimed is:
 1. A method, comprising: providing a pluralityof manifolds in a magazine, each manifold fluidly coupled by tubing to acontainer; providing the magazine in a recess of a pump head assembly ofa compounder system; aligning the plurality of manifolds with acorresponding plurality of ports in a pump cartridge; and extending aneedle from at least one of the manifolds into the corresponding port inthe pump cartridge to create a fluid pathway between the container thatis fluidly coupled to that manifold and the pump cartridge.
 2. Themethod of claim 1, wherein extending the needle comprises extending theneedle through a sealing member of the manifold into the pump cartridge.3. The method of claim 2, wherein providing the magazine in the recesscomprises inserting the magazine into the recess such that a pluralityof needle push rods of the pump head assembly are each engaged in a slotof a corresponding one of the manifolds, and wherein extending theneedle comprises extending the needle using a selected one of the needlepush rods.
 4. The method of claim 3, securing a needle guide assemblywithin a housing via at least one snap feature.
 5. The method of claim2, wherein the sealing member is disposed within a cap.
 6. The method ofclaim 5, further comprising securing the cap onto the manifold.
 7. Themethod of claim 6, further comprising radially compressing the sealingmember.
 8. The method of claim 7, wherein the sealing member is radiallycompressed approximately 10 percent of an original diameter of thesealing member.
 9. The method of claim 1, wherein aligning the pluralityof manifolds with the corresponding plurality of ports in the pumpcartridge comprises: rotating the magazine with the pump head assembly;and removing the pump cartridge from a carousel of cartridges to aposition adjacent the pump head assembly.
 10. The method of claim 1,further comprising allowing flow of a liquid or a vapor between thecontainer and the manifold and the pump cartridge.
 11. The method ofclaim 1, further comprising guiding the magazine into the recess via analignment feature.
 12. The method of claim 1, wherein a magazine housingcomprises a plurality of diluent manifold recesses and at least onewaste manifold recess each having alignment features, wherein thealignment features in the diluent manifold recesses are different fromthe alignment features in the waste manifold recess.
 13. The method ofclaim 11, further comprising facilitating installation of the magazineinto the recess via a pair of squeezable grips.